Francis Kombe

The World Conferences on Research Integrity have produced significant collaborative conference statements including the Singapore Statement on Research Integrity and more recently the Hong Principles on Researcher Assessment. The 7th World Conference on Research Integrity (7WCRI) takes place in Cape Town from the 29th May 2022 to 1st June 2022. The theme of the conference is Fostering Research in an unequal world. We have proposed the Cape Town statement on Fostering Research Integrity through the promotion of fairness, equity and diversity in research collaborations and contexts as the major collaborative output for this conference. This paper serves to introduce the reader and conference attendees to the motivation and thinking behind this proposal which will be discussed further at the conference.The proposed Cape Town Statement needs to accomplish two aims. First it must clearly demonstrate why inequity and unfair practices in research collaborations and contexts is a research integrity (RI) matter. Second it must identify some key values or principles and action guides that will address the issue of equity and fairness in research within the context of the complete research life cycle from research agenda setting and call to proposal development, through grant application, allocation and management of funding, data production, analysis, management and sharing, to outputs, translation, and evaluation.This background paper serves to outline the rationale and justification for the proposed Cape Town Statement as a major collaborative output of the 7WCRI. It is not in itself the proposed statement but rather represents a summary of some of the thought processes and contributions thus far. We argue that the domain of RI and previous WCRI RI statements have focused the RI project primarily at a micro and meso or project level, with researchers and institutions being the main target for guidance. The Cape Town Statement project aims to widen the lens, bring in a macro perspective and ensure that other role players, including those that support global research structures and systems, are brought into focus, and encouraged to take accountability for their own spheres of influence.

COVID‐19, caused by a novel coronavirus named SARS‐CoV‐2, was identified in December 2019, in Wuhan, China. It was first confirmed in sub‐Saharan Africa in Nigeria on 27 February 2020 and has since spread quickly to all sub‐Saharan African countries, causing more than 111,309 confirmed cases and 2,498 deaths as of 03 June 2020. The lessons learned during the recent Ebola virus disease (EVD) outbreaks in some sub‐Saharan African countries were expected to shape and influence the region’s responses to COVID‐19 pandemic. However, some of the challenges associated with the management of the EVD outbreaks persist and create obstacles for the effective management of the COVID‐19 pandemic. This article describes the commonalities between the EVD epidemics and COVID‐19 pandemic, with a view to draw on lessons learned to effectively tackle the ongoing pandemic. Key successes, failures and lessons learned from previous EVD outbreaks are discussed. Recommendations on how these lessons can be translated to strengthen the COVID‐19 response in sub‐Saharan Africa are provided.

Introduction: Fieldworkers are part of the system that promotes scientific and ethical standards in research, through data collection, consenting and supporting research, due to their insider cultural knowledge and fluency in local languages. The credibility and integrity of health research, therefore, rely on how fieldworkers adhere to institutional and research procedures and guidelines. Objectives: This study mapped out existing practices in training, support and performance management of fieldworkers in Africa, described fieldworkers’ and their managers’ experiences, and lessons learnt. A consultative process, involving field managers from 15 international health research institutions, was used to identify appropriate ways of addressing the challenges fieldworkers face. Methods: In phase 1, we conducted 32 telephone interviews with 20 field managers and 12 senior fieldworkers from 18 major research centres in Africa, Medical Research Council-UK and the INDEPTH Network Secretariat. In phase 2, we held a 2.5-day workshop involving 25 delegates, including 18 field managers from the institutions that were involved in phase 1 and 7 additional stakeholders from the KEMRI Wellcome Trust Research Programme (KWTRP). An earlier report from phase 1 was published in BMC Med ical Ethics in 2015. Data transcribed from the interviews and workshop proceedings were analysed thematically using NVivo V.10 software. Results: Most institutions employed fieldworkers, usually with 12 years of formal education and residing within the geographical areas of research, to support studies. Although their roles were common, there were marked differences in the type of training, professional development schemes and fieldworkers support. Fieldworkers faced various challenges, with the potential to affect their ethical and scientific practices. Discussion: Fieldworkers undertake vital tasks that promote data quality and ethical practice in research. There is a need for research institutions to develop a structured support system, provide fieldworkers with interpersonal skills training, and provide space for discussion, reflection and experience sharing to help fieldworkers tackle the practical and ethical challenges they face.

The integrity of biomedical research depends heavily on the quality of research data collected. In turn, data quality depends on processes of data collection, a task undertaken by frontline research staff in many research programmes in Africa and elsewhere. These frontline research staff often have additional responsibilities including translating and communicating research in local languages, seeking informed consent for study participation and maintaining supportive relationships between research institutions and study participants and wider communities. The level of skills that fieldworkers need to undertake these responsibilities clearly affects the quality of data collected, the ethics of research ‘on the ground’ and the short and long term acceptability of research. We organised an international workshop in Kenya in July 2014 to discuss the role of frontline staff in scientific research. A total of 25 field managers from 9 African countries and the UK met for 2.5 days to discuss the relationship between data quality and institutional performance management systems and how they affect career progression and supportive supervision policies of research frontline staff. From this workshop, and supporting an expanding literature on the role of fieldworkers in international health research, participants agreed that fieldworkers’ roles present them with practical and ethical challenges that their routine training does not adequately prepare them for. We argue that the common and complex challenges facing fieldworkers should in part be addressed through increased investment and collaborative agreements across types of research institutions in Africa. We call for standardization of core elements of training for this critically important cadre of research staff who perform similar roles and encounter similar challenges in many African settings. Although many valuable training elements are offered in institutions, there is a need to develop broader, more grounded and innovative strategies to address complex realities for fieldworkers, and support the integrity and ethics of health research in these settings.

The Ebola Virus Disease (EVD) in West Africa has stimulated investments in EVD research. While these research efforts are most welcome, we are concerned about the potential to ignore effective community ethics engagement programmes and critical government regulatory agencies in light of the urgency to conduct clinical trials for EVD therapies and vaccines. We discuss the reasons why community engagement with various research stakeholders is essential, how community engagement should be conducted, and the potential consequences of failing to engage both communities and regulatory agencies by drawing on past experiences in the field of HIV research. We highlight the importance of a) capacity building to enable local researchers design and implement EVD research for future epidemics, b) the need to support community research literacy, and c) the need to build the competency of research regulatory agencies on the continent to address EVD therapy and vaccine research.

There is increasing recognition of the importance of sharing research data within the international scientific community, but also of the ethical and social challenges this presents, particularly in the context of structural inequities and varied capacity in international research. Public involvement is essential to building locally responsive research policies, including on data sharing, but little research has involved stakeholders from low-to-middle income countries. Between January and June 2014, a qualitative study was conducted in Kenya involving sixty stakeholders with varying experiences of research in a deliberative process to explore views on benefits and challenges in research data sharing. In-depth interviews and extended small group discussions based on information sharing and facilitated debate were used to collect data. Data were analysed using Framework Analysis, and charting flow and dynamics in debates. The findings highlight both the opportunities and challenges of communicating about this complex and relatively novel topic for many stakeholders. For more and less research-experienced stakeholders, ethical research data sharing is likely to rest on the development and implementation of appropriate trust-building processes, linked to local perceptions of benefits and challenges. The central nature of trust is underpinned by uncertainties around who might request what data, for what purpose and when. Key benefits perceived in this consultation were concerned with the promotion of public health through science, with legitimate beneficiaries defined differently by different groups. Important challenges were risks to the interests of study participants, communities and originating researchers through stigmatisation, loss of privacy, impacting autonomy and unfair competition, including through forms of intentional and unintentional 'misuse' of data. Risks were also seen for science. Given background structural inequities in much international research, building trust in this low-to-middle income setting includes ensuring that the interests of study participants, primary communities and originating researchers will be promoted as far as possible, as well as protected. Important ways of building trust in data sharing include involving the public in policy development and implementation, promoting scientific collaborations around data sharing and building close partnerships between researchers and government health authorities to provide checks and balances on data sharing, and promote near and long-term translational benefits.

Increased global sharing of public health research data has potential to advance scientific progress but may present challenges to the interests of research stakeholders, particularly in low-to-middle income countries. Policies for data sharing should be responsive to public views, but there is little evidence of the systematic study of these from low-income countries. This qualitative study explored views on fair data-sharing processes among 60 stakeholders in Kenya with varying research experience, using a deliberative approach. Stakeholders’ attitudes were informed by perceptions of benefit and concerns for research data sharing, including risks of stigmatization, loss of privacy, and undermining scientific careers and validity, reported in detail elsewhere. In this article, we discuss institutional trust-building processes seen as central to perceptions of fairness in sharing research data in this setting, including forms of community involvement, individual prior awareness and agreement to data sharing, independence and accountability of governance mechanisms, and operating under a national framework.

Providing benefits and payments to participants in health research, either in cash or in kind, is a common but ethically controversial practice. While much literature has concentrated on appropriate levels of benefits or payments, this paper focuses on less well explored ethical issues around the nature of study benefits, drawing on views of community members living close to an international health research centre in Kenya. The consultation, including 90 residents purposively chosen to reflect diversity, used a two-stage deliberative process. Five half-day workshops were each followed by between two and four small group discussions, within a two week period (total 16 groups). During workshops and small groups, facilitators used participatory methods to share information, and promote reflection and debate on ethical issues around types of benefits, including cash, goods, medical and community benefits. Data from workshop and field notes, and voice recordings of small group discussions, were managed using Nvivo 10 and analysed using a Framework Analysis approach. The methods generated in-depth discussion with high levels of engagement. Particularly for the most-poor, under-compensation of time in research carries risks of serious harm. Cash payments may best support compensation of costs experienced; while highly valued, goods and medical benefits may be more appropriate as an ‘appreciation’ or incentive for participation. Community benefits were seen as important in supporting but not replacing individual-level benefits, and in building trust in researcher-community relations. Cash payments were seen to have higher risks of undue inducement, commercialising relationships and generating family conflicts than other benefits, particularly where payments are high. Researchers should consider and account for burdens families may experience when children are involved in research. Careful context-specific research planning and skilled and consistent communication about study benefits and payments are important, including in mitigating potential negative effects.

Planning study benefits and payments for participants in international health research in low- income settings can be a difficult and controversial process, with particular challenges in balancing risks of undue inducement and exploitation and understanding how researchers should take account of background inequities. At an international health research programme in Kenya, this study aimed to map local residents' informed and reasoned views on the effects of different levels of study benefits and payments to inform local policy and wider debates in international research. Using a relatively novel two-stage process community consultation approach, five participatory workshops involving 90 local residents from diverse constituencies were followed by 15 small group discussions, with components of information-sharing, deliberation and reflection to situate normative reasoning within debates. Framework Analysis drew inductively and deductively on voice- recorded discussions and field notes supported by Nvivo 10 software, and the international research ethics literature. Community members' views on study benefits and payments were diverse, with complex contextual influences and interplay between risks of giving ‘too many’ and ‘too few’ benefits, including the role of cash. While recognising important risks for free choice, research relationships and community values in giving ‘too many’, the greatest concerns were risks of unfairness in giving ‘too few’ benefits, given difficulties in assessing indirect costs of participation and the serious consequences for families of underestimation, related to perceptions of researchers' responsibilities. Providing benefits and payments to participants in international research in low-income settings is an essential means by which researchers meet individual-level and structural forms of ethical responsibilities, but understanding how this can be achieved requires a careful account of social realities and local judgment. Concerns about undue inducement in low-income communities may often be misplaced; we argue that greater attention should be placed on avoiding unfairness, particularly for the most-poor.